For those of us focusing our daily efforts on the subject of personalized medicine, it is refreshing to see so much chatter lately about market events centered on targeted therapies and their companion diagnostics (CDx). In our view, such chatter is a good indicator of a broadening awareness of personalized medicine which, in turn, demands greater insight for more people involved. Patterns of CDx activity and a clearer understanding of their limitations are clearly emerging and are being addressed by our clients and their peers, with oncology clearly at the vanguard, closely chased by the neurology, autoimmune and cardiovascular disease areas.

But we are reminded every day of our work in this area that the development of the CDx market is still in its infancy and with increased use of testing, new and often even harder challenges to crack will come, in our humble opinion. As we look at the key drivers of CDx market evolution, our eyes are not just on the trends we see today, the increasing number of companion tests being launched and the emerging influence of pathologists and laboratorians, but also on the longer term consequences of that success.

Two particular challenges jump out at us as requiring some better planning and preparation: the cost of testing and the quality of testing. Diagnostic costs in general have always been regarded as well managed within health care systems and have until now only very occasionally been the focus of intense scrutiny. This is perhaps not a huge surprise as today the costs of most tests remains so low compared to the annual or even lifetime costs of many therapies, in particular novel therapies. However, as we move past the cost of testing ‘only’ 40,000 patients for a specific $250 biomarker in lung cancer into testing for multiple biomarkers in 400,000 patients in rheumatoid arthritis, for example, the cost of testing will soon become a central issue. This is particularly true if and where the costs of such tests themselves are in a region far, far above the current two-digit standard for most routine clinical diagnostics. And that is just the beginning. Things will get much more difficult when one in three of each of these tests triggers the need – or should we say, a justification – for a treatment costing $5,000 or maybe even $25,000 per year.

Who pays for testing is a debate that today, if at all, still happens largely behind closed doors amongst the stakeholders involved. But this “don’t ask, don’t tell” attitude will not be sustainable for much longer, nor will the issue of test quality remain out of the spotlight forever. The FDA’s approach to incorporate a statement to utilize the FDA-approved test into the indications in the drug label is one solution, but certainly does not address the concerns around testing standards in every US lab. It also has only limited impact on testing in the rest of the world, and may be very difficult to enforce in indications requiring IVDMIA tests. In our view, the roll out of specific FDA-cleared kits developed as fit-for-purpose solutions is a laudable step in principle, if carried out with the required care and consideration for the needs of the various stakeholders involved in testing. Still, this ultimately may not address all, or even the majority, of future laboratory needs.

What might be a better, more directly market-driven solution is for all of us to better understand and quantify the real clinical and financial impact of each 10 per cent increase in diagnostic quality – in other words, to properly calculate the cost of inter- and intra-laboratory variability and low test sensitivity or specificity. Such understanding will likely provide a better rationale for sufficient pre-launch investment in quality improvement, coordinated thinking and collaboration across stakeholders impacting and impacted by the quality of testing. This understanding though will not simply emerge from introducing some vaguely defined ‘test rate’ line item into existing forecasting and health economic models originally developed for therapies not requiring specific testing, however sophisticated these may be. What is required is an in depth disassembly and reassembly of 1) the critical cost drivers in the provision of health services, 2) that appropriately mirror all the different influences that cost and quality of testing will have on the broader economics of a particular therapy, 3) of the disease or therapy area and, 4) ultimately, the health care system as a whole.

So, beyond all the happy chatter about how companion testing is now fast becoming a mainstream feature of novel therapy launches, the true acid test for the new personalized medicine paradigm still lies ahead of us. Using a suitably apt metaphor in this the year of the Olympics [2012]: we have warmed up on the track, but now still have a triathlon to run.

At Diaceutics, we have invested substantial resources into building such a deeper understanding that will enable us to run the personalized medicine triathlon. This is done by researching emerging trends in the Health Economics and Market Access environments facing personalized medicine, the development of proprietary databases and financial models customized to mirror the specific features and interdependencies of drug/diagnostic combinations, and by working with and talking to our various clients faced with exactly these challenges. We are determined to keep these issues at the center of our work and continue to move the debate forward.

Webinars & Podcasts

August 9th, 2018

Podcast: Oncology Patient Research

Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...

Publications

Thought leaders at Diaceutics recently authored a peer-reviewed article that covers the ongoing national debate over diagnostics reform legislation in the United States. The article is now available online ahead of print in the Journal of Molecula...

BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.